When your device has 300โฆ 3,000โฆ or 12,000 requirements โ Verification & Validation has reached an entirely new scale. In this clip, Aaron Joseph talks about one of the most critical (and often underestimated) elements of medical device development: traceability. In highly complex systems like surgical robotics, without clear requirement-to-test traceability, even great engineering looks […]
The Shocking Scale of V&V Requirements Read More ยป
February 2026 Newsletter – Practical Approaches for Risk Management and V&V
Newsletter V. 2026 Issue 3 Read More ยป
April 2026 Better risk management for medical devices
Newsletter V. 2026 Issue 2 Read More ยป
A Beginner’s Guide to Medical Device Risk Management Last updated: 23-MAY-2026 Curated by:ย Nishitha Cherukuri, Sharanya Kumar, Aaron Joseph Introduction Medical device risk management can feel overwhelming when you first encounter it. There are formal standards, dense terminology, and strong opinions about what โgoodโ looks like. This guide simplifies the starting point. It brings together
Medical Device Risk Management Starter Kit Read More ยป
Common risk management mistakes and misconceptions Risk management is crucial to medical device development but thereโs still a lot of confusion about what it is and why we do it. Hereโs a list of the most common risk management mistakes and misconceptions Iโve encountered. Hopefully, greater awareness of these will help product teams and companies
Common Errors in Medical Device Risk Management Read More ยป
February 2026 Newsletter – Practical Approaches for Risk Management and V&V
Newsletter V. 2026 Issue 1 Read More ยป
V&V is traditionally viewed as the final phase of medical device development, but successful teams begin preparing for it from the start. While formal, documented Verification & Validation occurs at the end to demonstrate compliance, effective development integrates testing throughout. This includes developing test methods, building tools, and evaluating prototypes early and often. Waiting until
When should V&V really start in medical device development? Read More ยป
Iโve helped many medical device development teams with formal risk assessment and Iโm often asked, โWhy do we need to do this?โ This question doesnโt mean they donโt care about product safety. They just donโt see the value in the formal process and documentation. Compiling a documented risk assessment is difficult and time consuming. It
Why Do We Need Formal Risk Assessment? Read More ยป
